FDA Identifies "Fatal Flaws" That Block Approval Of Health Claims
FDA likely will refuse new health claims applications if petitioners fail to provide relevant studies in healthy humans that evaluate the relationship between the substance and the disease, an agency official says
Learn what's happening at the US FDA. On the go.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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